Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients

Inclusion Criteria

• Hepatitis C infection for ≥ 1 year. Viral load at entry will be measured by the Amplicor Hepatitis C Virus Test Version 2.0 (Roche Molecular Systems; Plesasanton, CA) and genotyped by Trugene HCV 5'NC Genotyping kit (Visible Genetics; Toronto, Canada) performed within 90 days prior to study entry by a lab(s) certified for the assays.
• Male or female ages 18-65 years, inclusive.
• Plasma hepatitis C RNA of >105 copies/mL (or equivalent international units)
• Laboratory values: stable hepatic, renal, and hematological indices obtained within 30 days prior to study entry, as follows:
• Absolute neutrophil count (ANC) >= 750/mm³
• Hemoglobin >= 10.0 g/dL
• Platelet count >= 100,000/mm3
• Creatinine = 3 g/dL
• Normal PT and PTT
• Serum lipase = 20 µg/dL
• Normal fasting glucose
• Urinalysis free of clinically significant abnormalities NOTE: Fasting is defined as no oral intake except water for at least 8 hours prior to the study visit.
• Female subjects of reproductive potential (girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months or have not undergone surgical sterilization [e.g., hysterectomy, bilateral oophorectomy, or salpingotomy]) must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, before initiating study medication.
• All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, or in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the subject/partner must agree to use two reliable methods of contraception simultaneously (condoms with a spermicidal agent; or a diaphragm or cervical cap with spermicide) while on study drug and for 30 days after stopping the medication.
• Female subjects, who are not of reproductive potential, are eligible without requiring the use of contraception. Male subjects must use a condom with every sexual act that could lead to pregnancy.

NOTE: Acceptable documentation of sterilization is either written or oral documentation communicated by clinician or clinician's staff of one of the following: physician report/letter: operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy); discharge summary; laboratory report of azoospermia; or FSH measurement elevated into the menopausal range as established by the reporting laboratory.

• Karnofsky performance score >= 80 within 30 days prior to study entry.
• Ability and willingness of subject to give written informed consent.
• Willingness to return for a follow-up visit on day 56.
• Subjects taking any precautionary concomitant medications (see section 5.2.2) must be on stable doses for >8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study.

Exclusion Criteria

• Receipt of anti-hepatitis C therapy within the 4 weeks prior to study entry or intent to initiate ant-hepatitis C therapy within 60 days after entry.
• Clinical evidence of cirrhosis or decompensated liver failure.
• Chronic or acute adrenal failure, history of active hepatitis B, HIV-1 infection, porphyrias, known moderate to severe cirrhosis, hemorrhagic disorders, concurrent anticoagulant therapy, any prior pituitary tumor, surgery, radiation treatment, or pituitary failure.
• Diabetes requiring treatment with oral hypoglycemics or insulin therapy.
• Pregnancy within 90 days prior to study entry.
• Breast-feeding.
• Dysfunctional uterine bleeding within the 12 months prior to study entry.
• Any current hormonal contraception or IUD use.
• Use of drugs that are inhibitors or inducers of metabolism by the CYP 3A4 within 7 days of study entry.
• Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry.

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